The European Commission (EC) should exempt advanced therapies from Genetically Modified Organism (GMO) legislation, said the Alliance for Regenerative Medicine (ARM), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Association of Bioindustries (EuropaBio) in a paper published online in the journal Human Gene Therapy. The industry bodies maintain that the GMO legislation hurts Europe’s ability to attract clinical trials and delays patient access to transformative medicines
The original GMO legislation was primarily enacted to protect food consumers and the environment, but Advanced Therapy Medicinal Products (ATMPs) such as gene therapies are affected as an unintended consequence. The uneven application of GMO requirements across EU Member States causes significant clinical trial delays despite findings that gene therapies pose a negligible risk to the environment.
The EC granted a temporary derogation from GMO requirements to investigational COVID-19 medicinal products to accelerate the development of vaccines and treatments, recognizing that ”time was of the essence” during the pandemic, said Paige Bischoff, ARM’s Senior Vice President of Global Public Affairs. But she added: “Time is also very much of the essence for people with cancer, inherited disorders and other life-threatening conditions. We call on the European Commission to take the same measures for advanced therapies and remove the unnecessary and unintended burden of GMO legislation so patients have timely access to transformative, potentially curative medicines.”
The organizations call on the EC to put forward a proposal by 2022, the timeframe proposed by the Pharmaceutical Strategy for Europe. Violeta Georgieva, EuropaBio’s Legal Affairs Manager, commented: “Freeing the conduct of clinical trials with investigational gene therapies from the heavy EU GMO administrative burden is critical for cutting-edge biotechnology companies.”
She added, “The use of CRISPR/Cas9, the latest promising tool in genome editing, can be overshadowed in the EU if developers and regulators are to follow the 2018 ruling of the EU Court of Justice, which puts the controversial GMO label on the Nobel Prize-winning CRISPR technology. Our hopes are set on the European Commission to improve patient access to revolutionary treatments by exempting them from the disproportionate and outdated GMO framework.”